FDA Adverse Event Malfunction Summary report: N

LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

MDR report key: 2981489 · Received February 27, 2013

Report

Report Number: 3015876-2013-00155
Event Type: Malfunction
Date Received: February 27, 2013
Date of Event: February 1, 2013
Report Date: February 1, 2013
Manufacturer: PHYSIO-CONTROL, INC
Product Code: MKJ
PMA / PMN Number: K102972
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PARAMEDIC

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS NOT ABLE TO DUPLICATE THE REPORTED FAILURE. PHYSIO FOUND THAT THE UNIT POWERED ON AND DELIVERED APPROPRIATE DEFIBRILLATION THERAPY WHEN PROMPTED. PHYSIO DID OBSERVE THAT THE POWER WOULD INTERMITTENTLY FLUCTUATE SLIGHTLY WHEN THE MONITOR WAS MOVED, OR BUMPED, BUT IT NEVER FULLY POWERED OFF. AS A PRECAUTION PHYSIO REPLACED THE BATTERY PINS AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED BATTERY PINS AND CONFIRMED THAT THEY WERE VERY WORN AND BEGAN LOSING THEIR SHAPE. THE LIKELY CAUSE OF THE REPORTED FAILURE WAS WORN BATTERY PINS.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE MONITORING A PATIENT THEIR DEVICE SHUT DOWN BY ITSELF. THE CUSTOMER WAS ABLE TO POWER THE DEVICE BACK ON, BUT THE ECG CONTINUED TO SHOW JUST DASHED LINES. A BACKUP MONITOR WAS BROUGHT TO THE SCENE WITHIN FOUR (4) MINUTES AND THEY USED THE BACKUP DEVICE TO CONTINUE PATIENT CARE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
84807	LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES	DEFIBRILLATORS, AUTOMATIC, EXTERNAL	MKJ	PHYSIO-CONTROL, INC

Patients

Seq	Age	Sex	Outcome	Treatment
1